Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.

Lumbar Spine Adaptation Clinical Trial

— Mattress&Spine  

Official title:

Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638374
• Other study ID #: Mattress & Spine
• Status: Recruiting
• Start date: November 4, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2020
• Source: Istituto Ortopedico Galeazzi
• Contact: Jacopo A Vitale, PhD
• Phone: +390266214980
• Email: jacopo.vitale[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. The primary objective is the assessment of the variation in the lumbar lordosis angle (sagittal plane) in the supine position, on a mattress, compared to the value measured in the supine position on a rigid surface.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 45 years old

• Female or Male sex

• Cognitive integrity

• Absence of usual contraindications to MRI

Exclusion Criteria:

• Clinical condition diagnosed by a doctor

• Spinal pathologies

• Pregnant woman

• Claustrophobia

Related Conditions & MeSH terms

• Lumbar Spine Adaptation

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of lumbar section of spine in a supine position on a mattress	Magnetic Risonance is used to assess the spine	10 minutes
Primary	Evaluation of lumbar section of spine in a supine position without mattress	Magnetic Risonance is used to assess the spine	10 minutes
Secondary	Evaluation of lumbar section of spine in a standing position	EOS is used to assess the spine	2 minutes